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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Transport of dangerous goods, special recommendations relating to Class 8, United Nations handbook, 1977.
Deviations:
no
GLP compliance:
no
Remarks:
Study performed before GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
N-benzyl-N,N-dimethyltetradecan-1-aminium chloride
EC Number:
939-253-5
Cas Number:
68424-85-1
Molecular formula:
C12-14H25-29-(CH3)2-C6H5-N.Cl
IUPAC Name:
N-benzyl-N,N-dimethyltetradecan-1-aminium chloride
Constituent 2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Concentration: 50 % active substance
Duration of treatment / exposure:
4h
Observation period:
24, 48 and 72h
Number of animals:
1 in pre-test; 3 in main test
Details on study design:
- An amount of 0.5 mL of undiluted test substance (50% a.i.) was applied under occluded dressing onto the skin of 1 rabbit for 3’, 30’, 60’, and 4h. The skin was washed with water upon removal. 
- Observations: 24, 48 and 72h.
- A confirmatory study was performed at 3 min and 60 min applications in 3 rabbits each.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
60 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 2.6
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: skin corrosive
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Remarks:
60 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.9
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: skin corrosive
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
Details:
After 3 min: Well-defined erythema with moderate oedema at 72h; 
After 30 min: Severe erythema (necrotic reaction) with slight oedema;
After 60 min: Moderate to severe erythema with moderate oedema at 72h;
After 4h: Severe erythema (necrotic reaction) with severe oedema. 
Primary Irritation Index: 7.0
- Main study in 3 rabbits, 2 sites each with exposure for 3 min, and another 3 rabbits for 60 min. 
Effects at 3 min: no dermal reactions at any of the six sites.
Effects at 60 min: Moderate erythema with slight oedema at 4 sites and areas of skin necrosis at the other two sites.
Primary irritation index PII: 3 min: 0; 60 min: 4.5
50% active substance was corrosive to the skin

Applicant's summary and conclusion

Interpretation of results:
other: Category 1B (Corrosive) based on CLP criteria
Conclusions:
Under the conditions of the study, the test substance solution was considered to be corrosive to rabbit skin.
Executive summary:

A study was conducted to determine the skin irritation / corrosion potential of the test substance, C12-16 ADBAC (50% active in water) according to the method 'Transport of dangerous goods, special recommendations relating to Class 8, United Nations handbook, 1977'. In this experiment, 0.5 mL of a the undiluted test substance (50% active) was applied under occlusive dressing to the skin of 1 rabbit for 3, 30, 60 min and 4 h. The skin was washed with water upon removal of the dressing. Observations were recorded at 24, 48 and 72 h. A confirmatory study was performed with 3 min or 1 h applications in 3 rabbits each. In the main study, no dermal reactions were observed at any of the 6 sites after 3 min application. Moderate erythema (mean score: 2.6) with slight oedema (mean score: 1.9) at 4 sites and areas of skin necrosis at the other 2 sites were observed following 1 h application (Primary irritation index PII: 3 min: 0; 60 min: 4.5). Under the conditions of the study, the test substance solution was considered to be corrosive to rabbit skin (Liggit, 1982).